title: Current practice of darbepoetin alfa in the management of haemoglobin levels in cancer patients undergoing chemotherapy - data from the CHOICE study.
abstract: OBJECTIVE
  To evaluate adherence to European Organisation for Research and Treatment of Cancer (EORTC) and European Summary of Product Characteristic (SmPC) guidance on recommended haemoglobin (Hb) values in routine clinical practice use of darbepoetin alfa (DA) in cancer patients internationally.
  
  
  METHODS
  This multicentre, prospective, observational study assessed DA use in 11 European countries. This interim analysis (IA) included ∼1300 breast, colorectal, ovarian or lung cancer patients receiving DA during any chemotherapy cycle. Hb level and red blood cell (RBC) transfusion requirement data were collected.
  
  
  RESULTS
  Of the 1290 patients (mean [SD] age 62.5 [11.1] years) included in this IA full analysis set, 499 had lung, 387 breast, 192 colorectal and 212 ovarian cancer. Mean baseline Hb levels were <10 g/dL. At week 9, 426 (33%) patients had a Hb level of 10-12 g/dL, 165 (13%) of >12 g/dL, 226 (18%) of <10 g/dL and 473 (37%) had missing Hb values. 54% of the 672 patients still on the study at week 9 with available Hb values had Hb values of 10-12 g/dL. For patients with a baseline Hb of <10 g/dL, the Kaplan-Meier (K-M) percentage of patients with Hb levels ≥10 g/dL from week 1 to end of treatment period (EOTP) was 86%. For these patients, the K-M% of patients with Hb levels >13 g/dL from week 1 to EOTP was 10%. The K-M% of patients requiring RBC transfusions from week 5 to EOTP was 26% for all patients. Seven patients reported treatment-related non-serious adverse drug reactions, four were thromboses.
  
  
  CONCLUSIONS
  This IA suggests most patients were treated according to European SmPC guidance. Hb evolution during the study is consistent with data from clinical trials, implying DA is effective in increasing Hb levels in chemotherapy-induced anaemia patients. Hb levels >13 g/dL were infrequent. Limitations are related to the observational nature of this study.
authors.affiliation: Department of Medical Oncology, University Hospital Ghent, Ghent, Belgium. simon.vanbelle@ugent.be
authors.forename: S
authors.initials: S
authors.lastname: Van Belle
authors.forename: C
authors.initials: C
authors.lastname: Karanikiotis
authors.forename: J-L
authors.initials: JL
authors.lastname: Labourey
authors.forename: A
authors.initials: A
authors.lastname: Galid
authors.forename: T
authors.initials: T
authors.lastname: Wheeler
authors.forename: B
authors.initials: B
authors.lastname: Pujol
mesh_terms: D000368:Aged; D000068256:Darbepoetin alfa; D017707:Erythrocyte Transfusion; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005060:Europe; D005260:Female; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006454:Hemoglobins / Q000032:analysis / Q000378:metabolism*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood* / Q000628:therapy*; D011446:Prospective Studies; D013997:Time Factors
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa